Novel Minimal Radiation Approach for Percutaneous Pulmonary Valve Implantation.

The aim of the study is to evaluate the impact of multimodality imaging technology during percutaneous pulmonary valve implantation (PPVI). Among percutaneous procedures, PPVI traditionally has one of the highest patient radiation exposures. Different protocol modifications have been implemented to address this problem (i.e., improvements in guidance systems, delivery systems, valve design, post-implantation evaluation). Although the effectiveness of individual modifications has been proven, the effect of an approach which combines these changes has not been reported. We performed a retrospective chart review of 76 patients who underwent PPVI between January 2018 and December 2019. Patients were classified in "Traditional protocol," using routine biplane angiography and/or 3D rotational angiography (3DRA); and "Multimodality protocol" that included the use of VesselNavigator for guidance, selective 3DRA for coronary evaluation, Long DrySeal Sheath for valve delivery, and Intracardiac Echocardiography for valve evaluation after implantation. Radiation metrics, procedural time, and clinical outcomes were compared between groups. When the traditional protocol group was compared with the multimodality protocol group, a significant reduction was described for total fluoroscopy time (31.6 min vs. 26.2 min), dose of contrast per kilogram (1.8 mL/Kg vs. 0.9 mL/Kg), DAP/kg (26.6 µGy·m2/kg vs. 19.9 µGy·m2/kg), and Air Kerma (194 mGy vs. 99.9 mGy). A reduction for procedure time was noted (140 min vs. 116.5 min), but this was not statistically significant. There was no difference in clinical outcomes or the presence of complications between groups. The combination of novel technology in PPVI caused a significant reduction in radiation metrics without increasing the complication rate in our population.

Coronary compression testing by balloon interrogation during pulmonary valve implantation: room for doubt?

OBJECTIVE: To evaluate the reliability of balloon coronary compression testing during percutaneous pulmonary valve implantation. BACKGROUND: Despite the widespread use of the 'balloon coronary test' as the preferable method to rule out the risk of coronary compression, this adverse event has been described after pulmonary valve implantation where coronary balloon test suggested no risk or low risk, calling into question the accuracy of the test. METHODS: We performed a retrospective chart review of 84 patients who underwent pulmonary valve implantation between January 2018 and December 2019 and selected 36 patients whose archived imaging was suitable to perform quantitative analysis of the 'balloon coronary test'. We focused on the spatial disparity between the right ventricular outflow tract position defined by the inflated testing balloon and the eventual implanted valve position, to classify the test as inaccurate or accurate. RESULTS: In total, 36.1% of cases were classified as having an inaccurate coronary balloon test. Among the baseline characteristics, right ventricular outflow tract substrate was identified as a significant predictor of test accuracy. Related to this characteristic, the type of testing balloon used and the size of the eventually implanted valve were found to be associated with test accuracy. CONCLUSIONS: Based on our findings, balloon coronary testing is not an accurate method of predicting final valve position with respect to fixed structures in the thorax. This may translate to a high false positive rate for the likelihood of coronary compression in pulmonary valve implantation.

Different CMR Imaging Modalities for Native and Patch-Repaired Right Ventricular Outflow Tract Sizing: Impact on Percutaneous Pulmonary Valve Replacement Planning.

Percutaneous pulmonary valve replacement (PPVI) in native or patched right ventricular outflow tract (RVOT) has proven to be feasible. The procedure is highly dependent on the size of the RVOT. Several methods exist to evaluate the size of the RVOT by cardiovascular magnetic resonance (CMR). We evaluated different CMR modalities for measuring RVOT diameters. Thirty-one consecutive patients with native or patched RVOT were retrospectively evaluated. CMR was part of follow-up of patients with corrected Tetralogy of Fallot or pulmonary stenosis with significant pulmonary regurgitation (PR). CMR included 3D-SSFP whole-heart in systole, diastole, and contrast-enhanced MR angiography (ceMRA). Diameters of the RVOT were assessed by the three sequences. Additionally, in patients who underwent cardiac catheterization (n = 11) for PPVI, vessel diameters assessed by cine-angiography were compared to CMR. Systolic diameters of RVOT were significantly larger compared to the diameters taken in diastole and ceMRA (median difference 5.0 mm and 3.8 mm). Diastolic and ceMRA diameters did not differ significantly. CMR diameters taken in systole showed no statistical difference to systolic diameters taken by cine-angiography, while diastolic and ceMRA diameters were significantly smaller. PPVI was feasible to a maximal CMR diameter of 31 mm measured by SSFP whole-heart sequence in systole. Absolute diameters of native RVOT differ depending on the CMR sequence and timing of acquisition (systolic vs diastolic gating). Diameters taken during heart catheterization by cine-angiography best correlate to systolic CMR values. Data may help to select RVOTs suitable for PPVI.

SAPIEN valve for percutaneous transcatheter pulmonary valve replacement without "pre-stenting": A multi-institutional experience.

OBJECTIVES: To describe a multicenter experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards SAPIEN S3 valve without the use of a prior stent ("pre-stenting"). BACKGROUND: The SAPIEN S3 and XT valves have durable cobalt-chromium stent frames which may allow for TPVR in large diameter dysfunctional right ventricular outflow tracts (RVOTs) without pre-stenting the landing zone. METHODS: A retrospective review was performed of all patients with Congenital Heart Disease and dysfunctional RVOT who underwent TPVR using the SAPIEN valve without the use of a pre-stent. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate short and intermediate-term results. RESULTS: Fifty-seven patients underwent percutaneous placement of the SAPIEN valve in the pulmonary position without the use of pre-stenting. The anatomical substrate varied: native RVOTs (n = 41), conduits (n = 10), and bioprosthetic valves (n = 6). There were no cases in which the valve could not be implanted and no cases of valve embolization or misplacement. On follow-up (range 1 month to 2.2 years, median 5.3 months), no patients had significant obstruction or regurgitation around the valve. There were no frame fractures. There were no procedural deaths. Major complications included severe aortic compression (n = 1) requiring surgical explantation and tricuspid valve injury requiring surgical intervention (n = 2). CONCLUSIONS: This limited multi-institutional experience demonstrates that the SAPIEN valve can be used for TPVR without the use of a pre-stent without medium-term risk of frame fracture, paravalvar leak, or embolization. Longer term follow-up is required to fully assess this method.

Usefulness of intracardiac echocardiography for the diagnosis of infective endocarditis following percutaneous pulmonary valve replacement.

Infective endocarditis is a serious complication occurring after percutaneous pulmonary valve replacement with a Melody valve; it is of uncertain incidence, and presents a challenging diagnosis. Vegetations may be difficult to visualise with transthoracic and transoesophageal echocardiography. We report the role of intracardiac echocardiography in this condition by confirming the prosthesis involvement.

Treatment of right ventricular outflow tract dysfunction: a multimodality approach.

The right timing to replace the pulmonary valve in a patient with dysfunction of the right ventricular outflow tract is unknown. Both percutaneous pulmonary valve and surgical prosthesis are suitable options. In every patient, the right ventricle (RV) remodels and recovers differently after pulmonary replacement. Therefore, it is difficult to identify the best treatment option and to predict the long-term results. In the last few years, we focused our research on optimizing the characterization of these patients through advanced cardiovascular imaging in order to find possible variables, parameters, and reproducible measurements that can help us in the decision-making process. The aim of the present article is to present our ongoing research lines that focus on the characterization and optimal treatment approach to the dysfunction of the RVOT.

Consecutive percutaneous valve-in-valve replacement late after Ross procedure: A novel approach in an adult with congenital heart disease.

The emergence of transcatheter valve technology over the last decade has made significant impact on the treatment of patients with valvular heart disease. There has been increasing experience with both native and valve-in-valve indications with promising results. We present the case of a young woman with congenital heart disease who underwent the Ross procedure for bicuspid aortic valve endocarditis with subsequent reoperation and surgical aortic valve replacement for neo-aortic root dilation who experienced worsening symptoms related to both pulmonary and aortic valve dysfunction. She was successfully treated with percutaneous pulmonary and aortic valve replacement with excellent early term technical results and marked improvement in symptoms.

Risk of Infective Endocarditis Post-transcatheter Pulmonary Valve Replacement Versus Surgical Pulmonary Valve Replacement: A Systematic Review.

Pulmonary valve replacement (PVR) is the most common cardiac operation in adult patients with congenital heart disease (ACHD). It can improve right ventricular outflow tract (RVOT) obstruction, typically due to pulmonary valve stenosis or regurgitation. PVR can be performed surgically (open-heart) and through a transcatheter (percutaneous) method, which is minimally invasive and is associated with shorter hospitalization stays. However, following PVR, infectious endocarditis (IE) can complicate the recovery process and increase mortality in the long term. IE is a rare but deadly multi-organ system condition caused by microorganisms traversing the bloodstream from a specific entry point. It can have many presentations, such as splinter hemorrhages, fevers, and vegetation on valves that lead to stroke consequences. This paper aims to evaluate the differences in the rate, etiology, manifestations, treatment, and outcomes of IE following surgical and transcatheter PVR, as the goal is to perform a procedure with few complications. In both approaches, Staphylococcus aureus was the most common microorganism that affected the valves, followed by Streptococcus viridians. Research has shown that surgical pulmonary valve replacement (SPVR) has a decreased risk of IE following surgery compared to TPVR. However, TPVR is preferred due to the reduced overall risk and complications of the procedure. Despite this, the consensus on mortality rates does differ. Future research should consider the type of valves used for transcatheter pulmonary valve replacement (TPVR), such as Melody valves versus Edward Sapien valves, as their IE rates vary significantly.

[Percutaneous treatment of the pulmonary valve]. / Traitement percutané de la valve pulmonaire.

Right ventricular outflow tract diseases are historically outcomes of surgical reconstruction for heart defects in neonates or children (Tetralogy of Fallot, Ross surgery). This kind of surgery performed during childhood lead often to dysfunctional right ventricular outflow tract (stenosis, leak) in older infants or young adults. In this case, reintervention on the right ventricular outflow tract would be associated with a high surgical risk. Development of the first percutaneous valves in the year 2000 paved the way for the pulmonary revalvulation. This percutaneous procedure has emerged as a credible alternative to the surgery for multioperated high risk patients with congenital cardiopathies. Two valves are currently available on the French market (Melody®, Sapien®); they cover all therapy indications, except the example of very wide outflow tracts which remain a surgical issue. Medical teams in charge of these young patients have to be enough trained in order to limit risks during the procedure. To this end, several teams promote the percutaneous pulmonary revalvulation over surgical revalvulation, this latter becoming limited only to cases in which percutaneous treatment is not feasible.

A reduced-order modeling for efficient design study of artificial valve in enlarged ventricular outflow tracts.

A computational approach is proposed for efficient design study of a reducer stent to be percutaneously implanted in enlarged right ventricular outflow tracts (RVOT). The need for such a device is driven by the absence of bovine or artificial valves which could be implanted in these RVOT to replace the absent or incompetent native valve, as is often the case over time after Tetralogy of Fallot repair. Hemodynamics are simulated in the stented RVOT via a reduce order model based on proper orthogonal decomposition, while the artificial valve is modeled as a thin resistive surface. The reduced order model is obtained from the numerical solution on a reference device configuration, then varying the geometrical parameters (diameter) for design purposes. To validate the approach, forces exerted on the valve and on the reducer are monitored, varying with geometrical parameters, and compared with the results of full CFD simulations. Such an approach could also be useful for uncertainty quantification.

Blood Flow Simulations for the Design of Stented Valve Reducer in Enlarged Ventricular Outflow Tracts.

Tetralogy of Fallot is a congenital heart disease characterized over time, after the initial repair, by the absence of a functioning pulmonary valve, which causes regurgitation, and by progressive enlargement of the right ventricle outflow tract (RVOT). Due to this pathological anatomy, available transcatheter valves are usually too small to be deployed there. To avoid surgical valve replacement, an alternative consists in implanting a reducer prior to or in combination with the valve. It has been shown in animal experiments to be promising, but with some limitations. The effect of a percutaneous pulmonary valve reducer on hemodynamics in enlarged RVOT is thus studied by computational modeling. To this aim, blood flow in the RVOT is modeled with CFD coupled to a simplified valve model and 0D downstream models. Simulations are performed in an image-based geometry and boundary conditions tuned to reproduce the pathological flow without the device. Different device designs are built and compared with the initial device-free state, or with the reducer alone. Results suggest that pressure loss is higher for the reducer alone than for the full device, and that the latter successfully restores hemodynamics to a healthy state and induces a more symmetric flow in the pulmonary arteries. Moreover, pressure forces on the reducer and on the valve have the same magnitudes. Migration would occur towards the right ventricle rather than the pulmonary arteries. Results support the thesis that the reducer does not introduce clinically significant pressure gradients, as was found in animal experiments. Such study could help transfer to patients.

Infective endocarditis following percutaneous pulmonary valve replacement: diagnostic challenges and application of intra-cardiac echocardiography.

BACKGROUND: Infective endocarditis (IE) following percutaneous pulmonary valve replacement (PPVR) with the Melody valve is rarely reported. Furthermore, there are challenges in this diagnosis; especially echocardiographic evidence of vegetation within the prosthesis may be difficult. METHOD AND RESULT: This study is a retrospective review of all patients with Melody valve implantation in a tertiary centre. Between November 2006 and November 2012, 43 procedures were performed in 42 patients (mean age 25 years, 6-67 years). At a median follow-up of 27 months (2-66 months), six patients were suspected for IE. However, repeated transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) showed no evidence of IE and the patients were diagnosed as possible cases according to the modified Duke's criteria. Two patients did not respond to antibiotic treatment and underwent intra-cardiac echocardiography (ICE), which clearly demonstrated vegetations. These two cases required surgical explantation, while the other four patients were treated medically without complications. CONCLUSION: IE after Melody valve implantation is uncommon, but difficult to verify since TTE and TEE often cannot demonstrate vegetations inside the stent. ICE should be considered in suspected cases of IE following PPVR with negative TTE and TEE examinations in order to early tailor the best treatment for the individual patient suspected for IE.

Percutaneous Therapies in the Treatment of Valvular Pulmonary Stenosis.

Transcatheter balloon pulmonary valvuloplasty (BPV) is the standard of care in managing symptomatic patients with moderate-to-severe pulmonary valvular stenosis, or asymptomatic patients with severe pulmonary valvular stenosis or with moderate pulmonary stenosis and evidence of objective exercise intolerance or right ventricular dysfunction. This article discusses the incidence, causes, and pathophysiology of valvular pulmonary stenosis in adolescents and adults; its natural history and noninvasive evaluation; the current guideline-recommended indications for BPV; the technical aspects of performing BPV; the immediate and long-term outcomes after valvuloplasty; and the complications and safety of the procedure. Also discussed is the role of this procedure in neonatal critical pulmonary stenosis and in percutaneous pulmonary valve replacement for patients with prior pulmonic valve interventions or degenerated right ventricular pulmonary artery conduits.